In 1998, Xeloda was approved in the U.S. for advanced breast cancer that had spread to distant sites in the body. The new trial, done in Japan and South Korea, tested the drug for a different group of patients.

It focused on 910 women whose breast tumors were not completely eliminated by standard chemotherapy and surgery. In addition, they all had cancer that lacked a protein called HER2 ó which meant they could not benefit from breast cancer drugs that target HER2, such as Herceptin.

Those women have a fairly high risk of seeing their cancer progress, according to the researchers on the trial, led by Dr. Masakazu Toi, of Kyoto University in Japan.

In the study, Xeloda improved those odds. It cut patients' risk of relapse or death by 30 percent over five years.

At that point, 74 percent were still alive and recurrence-free, versus just under 68 percent of women who'd received placebo pills in addition to standard treatment.

"It's not a panacea, by any means," Malamud said. "But it's a nice 'back door' treatment to improve women's outcomes."

Dr. Elizabeth Comen is a medical oncologist at Memorial Sloan Kettering Cancer Center in New York City. She said doctors have already begun using Xeloda for women like those in the trial, based on preliminary reports. (The trial was actually stopped early, in 2015, when it became clear that Xeloda had benefits.)

The women in the study all had breast tumors that had not yet spread to distant sites in the body. But many had cancer in nearby lymph nodes.

They'd all received standard chemotherapy before surgery, but still had "residual" cancer left behind.

Toi's team randomly assigned the patients to one of two groups. Most women in both groups received radiation, and those with hormone-sensitive breast cancer started on hormonal medications.

Only one group received Xeloda, while women in the other group were given placebo pills. The treatment was given in six or eight three-week "cycles," with two weeks on the drug, one week off.

Five years later, 89 percent of Xeloda patients were still alive, compared with just under 84 percent of placebo patients.

The difference was larger among women who had "triple-negative" breast cancer; that means their cancer not only lacked HER2, but was not hormone-sensitive, either ó which limits their treatment options.

Among those women, 79 percent of Xeloda patients were alive after five years, compared with 70 percent of placebo patients.

The main side effect -- affecting almost three-quarters of patients -- was hand-foot syndrome. That's a reddening and swelling of the palms and soles of the feet. It's similar, Malamud said, to a "bad sunburn," and it goes away once the drug is stopped.

As for access to the drug, both Malamud and Comen said they would be surprised if an insurer wouldn't pay.

The trial was funded by the Advanced Clinical Research Organization and Japan Breast Cancer Research Group.

The results were published in June in the New England Journal of Medicine.

Thanks for posting this, Donna. It's good to see the final article in the New England Journal of Medicine this month (it was worth the $20 for me to buy the article!). Among just the TNBC patients in the trial:

*. Disease free survival was 70% at 5 years for those on capecitabine/Xeloda vs. 56% for the control group (TNBC patients were a mix of Stage 1 - Stage 3B)

* Overall survival was 79% at 5 years for those on capecitabine/Xeloda vs 70% for the control group.

It was also encouraging to me to see that the steepest part of the curves was at the beginning. It looks like more than half of the recurrences that happened over the 5 year period occurred in the first 15 months, and then drastically diminished/flattened out after that. So yes, most of us are told 5 years is a fairly magical timeframe when the risk of recurrence is fairly minuscule after that period; but we can all start breathing quite a bit easier much sooner than that.

A year and a half ago I had to really advocate for my MO to prescribe the capecitabine to me when I learned I had residual TNBC after neoadjuvant chemo/surgery. He wasn't completely sold on the preliminary results reported at San Antonio in December 2015. Now it seems this will probably be close to standard practice to offer it with residual. I'm so glad I did my research and discovered these results; if I had not, I would be livid and regretful that this information was out there (albeit in preliminary form) and I hadn't had an opportunity to decide if it was right for me. There are further follow-up studies going on to confirm/repeat these types of findings, but it will be many years before that information is available. I'll never know if capecitabine specifically helped me (unless of course I recur, in which case I'll know that it did not--or at best delayed things), but it helps me to know that I took every reasonable step available to me.

One thing I find frustrating is that these trials don't allow us access to a scrubbed/no-names version of the data! I'd really like to cut the data myself, to look at people most similar to me (people with TNBC at my stage, my grade, my age group, who had similar neoadjuvant treatments, with same BRCA status, same LVI status, same RCB level, etc). I know we can't cut it that precisely (there were only about 300 total patients with TNBC in the study), but still, I'd love to play with the data myself to try to look at as relevant a population for me as possible. They had unleashed some points slicing the data in certain ways (response of those with lymph node involvement vs no lymph node involvement, for example), but that was for the whole study population (a combination of TNBC and HR+/HER2- patients)....I would have loved to see that info for just the TNBC patients, and other examples. For the trials to help guide our decision-making, access to this information can be really useful. I want to advocate for more transparency in trial reports!

Anyway, thanks for this. Capecitabine may not be the right choice for everyone who faces residual TNBC, but everyone should at least have access to this information to make an informed decision.

Thank You, Donna, I didn't realize this had been published. I can relate to Tulip's thoughts on having the specific data. I often wonder how women with my criteria are faring. Since I had surgery first (was not offered a choice), I did not receive any feedback regarding the efficacy of the chemotherapy. Thankfully, the tumor was small, but already in two lymph nodes. All I have is the survival estimate from my oncologist (77%). Was not offered the Xeloda. I did mention to my oncologist at a recent checkup that many women are following up with this after radiation, and he was unaware of it. So he did take a minute and looked at the preliminary data on his laptop. I wish my surgeon would have offered the option of doing chemo first, but was so scared at the time, I just did what they told me to do. I think the great mystery of cancer is why some women who are stage I recur and some women who are stage III do not. It's almost like a random "crapshoot" which never will make sense to any of us. I have finally gotten to the point I only worry about today and find joy in it. I will deal with tomorrow when it comes. My heart aches for those who post on this forum with a recurrence. So unfair, especially to those who are young. (I just turned 58 yo, so I have lived a good life; would appreciate more, but am thankful for what I have had.)

I'm glad you did your research and that your onc listened to you even with only preliminary results. Many times we are not given an option.

From the report: "The difference was larger among women who had "triple-negative" breast cancer". I agree with you - I wish they'd report by bc type too, just not overall results where everyone is lumped together.

I remember when I entered the phase 3 clinical trial - expanded access because the study was going so well they opened it up to everyone, only to find out it did not meet their "end points" and Iniparib was not granted FDA approval. I told my onc they needed to look at the subset of people that responded to this drug and chemo combination and see what they had in common. What was different about them vs the entire study sample? Was it breast cancer type, eg TNBC? BRCA status? Tumor genetic mutation(s)?

Hello Ladies!It looks like I will be doing oral chemo after surgery due to having to stop T after some nasty side effects. Can any of you tell me of your experiences on oral chemo? Hugs from Copenhagen,Elisa

I am on radiation right now and will be starting oral chemo, Xeloda, in three weeks. I, too, would like to know your experiences on it. Does everyone suffer the hand foot issues? How badly? Did you lose your hair? My hair is just starting to grow back after six months of chemo that I have been off for a couple of months. Thank you for replying.

I am on radiation right now and will be starting oral chemo, Xeloda, in three weeks. I, too, would like to know your experiences on it. Does everyone suffer the hand foot issues? How badly? Did you lose your hair? My hair is just starting to grow back after six months of chemo that I have been off for a couple of months. Thank you for replying.

Hello Michelle7 and Elisa, I've now finished my 5 cycle of Xeloda. Its been 3 weeks on and 1 week off. I am so grateful that my medical team have put me on the drug as the results from the Japanese study were very exciting. I had positive lymph nodes after neoadjuvant treatment and was put on Xeloda 4 weeks after surgery, mastectomy and full reconstruction.

In answering your question. I have tolerated it well, I work as a teacher and have been working full time. The first two cycles I experienced tiredness and in the second week of the cycle trouble sleeping. The cycles there after, dryness of my hands and feet, with blisters (not terribly painful). My fifth cycle, I've had diarrhea and my fingers cuticles bleeding, possibly from the dryness. I have been using an assortment of creams including urea creams, but have found regular cooking olive oil massaged in the best. Everyone reacts differently, but overall compared to AC and Taxol Chemo, its very tolerable. Oh and my hair has continued growing!!!

Hi Ladies. I am now in my third cycle (2 weeks on, 1 off). My first cycle I was on 75% of the full dose, and the second and third 87,5%. This third cycle is really starting to get to me. Generally speaking I have a good amount of fatigue, constant low grade nausea (have pills for that and itís ok), sporadic tummy issues, shakiness, a very difficult time sleeping (yay Ambien!) and now numbness on the bottoms of my feet and starting numbness in my fingers. And to boot? I am dumber than a box of hair. If I can remember my own name I feel like a winner! Talking to my oncologist today about dosage. Itís all in all still very tolerable, but Iím a hairdresser. So being on my feet and having to do my job well and interact is very difficult. Iíll update as time passes. Hope this helps.

Hello! I have been reading these boards since December of 2017 when my mom was diagnosed with TNBC. I, myself, work in a medical oncology office for almost 13 years--so it's safe to say I was blown away and felt like a nuclear war went off in my body when I found out about my mom since I kind of see the backside of things.

My mom was stage 2 (IDC 2.8cm mets to lymph node) when she was finally staged. She under went 4 cycles of Adria/Cytoxan then 12 weeks of taxol/carbo. She had a unilteral mastectomy with axillary dissection with immediate reconstruction with tissue expander a month ago. She had a partial response--her breast tumor/skin showed no cancer or residual diease and 2 out of the 6 LN were positive but showed treatment effects.

She will undergo radiation in a few weeks for 6 weeks more than likely. Then her doctor (who is also my boss) will put her on xeloda for 6 months. Which makes me happy since I read about this before her surgery and was kind of hoping he would put her on something since she can't do endocrine therapy.

She is doing amazing and I hope it will continue when she is placed on xeloda--she is just happy she won't lose her hair again. Granted she won't start for another couple of months, but it makes me breathe a bit better knowing she will be taking something.

Hi, I have been reading these boards since my diagnosis with TN IBC in November 2017. I was 53 and otherwise completely healthy.

I spotted the cancer myself ( a mammogram the previous year had shown nothing out of the ordinary) which manifested as a heavier, fuller feeling than usual right breast with a slight pinkish flush on one side. Further close investigation revealed a small patch of orange peel skin under the areola (this was hard to see as I have full breasts and it was hidden when looking in the mirror. A lying down, arm over the head self exam of the breast revealed a largeish (8cm across maybe) patch of firmer tissue, but you wouldn't really call it a lump.

All in all not much to see for the doctor, more just a feeling of not rightness for me.

I went straight to the GP who was fab - although he said he thought it was nothing to worry about and more likely the result of a bump to the breast (My big dog had jumped up on me a week or two prior and planted his massive paws on my boobs!). The GP referred me immediately for a mammogram and ultrasound. Once this was done a few days later, everything started to move like crazy. The day after the U/S I was called back for a biopsy and then the diagnosis of Stage III Grade 3 Triple Neg Inflammatory BC.

I've been very lucky to receive what I think from all my reading is Gold Standard treatment:

4 X 2 weekly cycles of AC )Doxyrubicin/Cyclophosphate)

12 x 1 weekly cycles Taxol (paclitaxel)

Modified radical mastectomy (Right Side) - I have chosen no reconstruction, although you have to wait a year or two with IBC in any case. I didn't get a PCR but apparently the residual cancer in the breast was only a millimetre or two across. Margins were great.

5 weeks radiation therapy

And now what I refer to as my "bonus round of chemotherapy" - 6 months of Capecitabine (Xeloda) given 2 weeks on, one week off.

I am only on my third day of this drug so will post a little later about how I go with side effects. I am a bit worried about the Hand/Foot syndrome as I had a very bad reaction to my first dose of Taxol and had super sore hands and feet, all the skin peeled off and I couldn't use my finger print to access my phone or security locks for nearly two months!

When the Oncologist first told me about the Capecitabine, my initial reaction was NO! I thought my treatment was over and I could concentrate on getting back to "normal"- I was very disappointed. I had a few weeks to think about it while I was undergoing radiation so I did as much reading as I could and read the results of the big 900 person trial (can't remember the name of it, sorry!) with statistics for improved survival/recurrence rates. Of course I realised that there are few drug therapies available to us TNBCers once our primary treatment cycle is complete, so despite my initial resistance I have of course agreed to try it.

One thing I have done for myself from early on in my treatment, after reading everything I could get my hands on, is to adopt a plant based, wholefood diet and completely stop drinking alcohol. I am convinced this has helped me enormously by giving my body underlying support to deal with the systemic poisoning that is chemotherapy and putting as little extra pressure on my organs as I could. I also believe that the reduction of animal proteins will help prevent a recurrence of the cancer for many reasons, but a big one is the effect of IGF (Insulin Like Growth factor - very high in meat, eggs and dairy products). IGF has been shown to feed tumour growth.

I am really shocked at the complete disregard for the importance of diet from almost every branch of the medical profession - surely this is a no-brainer? Despite the excellence of my care in every other way, none of my doctors wants to engage on the subject of diet. I'm amazed.

I've tried to keep walking every day (not always possible, but mostly I've managed it) and also tried to keep doing yoga - again not always possible, but I try to approach each day as a new start. I have kept working and best of all I've kept singing - this is very important physically as well as mentally! if you need something to help hold you up, join a choir!

Even though we know this is going to be a tough gig when we get our diagnosis, I don't know if any of us really get that what it actually means is that life will never be the same again - a year in, it's starting to dawn on me!

I'm so glad you shared your story. It's been a long road for you and so happy you have found your joy in singing. IBC is hard to detect and glad you knew something wasn't right. Sometimes you have to listen to that inner voice telling you something isn't right. Yes, life will never be the same, but somehow we become stronger facing this horrible disease. Keep us posted on how you are doing.

Thanks for taking the time to reply Donna, your message means a lot. Even though I have only just posted my little story, I have used this website (and the IBC site) often during the last year and it's been an invaluable resource. So good to hear from so many smart women taking reponsibility for their own health and so good to not feel quite so alone

Adding Capecitabine to Adjuvant Therapy Does not Improve Overall Survival in Early TNBC--With One ExceptionThis study was a phase 3 randomized trial in which one group of patients with early stage TNBC received capecitabine as adjuvant therapy after finishing neoadjuvant chemotherapy and surgery, while the other group got only the neoadjuvant treatment and surgery.. The CREATE-X trial showed no benefit either in disease free survival or overall survival for the patients getting the capecitabine. There was one group, however, for which the results were more promising--patients with the non-basal type of TNBC. That group did have statistically significant improvements in both key measures of the success of the treatment.

Effective treatment for early TNBC is critical as this is primary way to prevent the disease from recurring or spreading to other sites. Researchers are always working on ways to improve the initial treatments that patients receive. Itís also important not to subject patients to side effects from drugs or treatments that are not effective. This study will provide a basis for additional trials with the non-basal TNBC group and help refine the current standard of treatment for all women with TNBC.

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